Q2 2020 Ocular Therapeutix Inc Earnings Call
With the addition of o t x d e d along with OT xesi, we now have to potentially transformative products one to treat chronic forms of the disease and the other countries you've disease off there by effectively covering the broad spectrum of the approximate five billion dry eye disease Market.
And we're looking at device will remain on track to file an application by the end of the year. Notably allergic conjunctivitis represent extends his first ocular surface disease in a station and be the first indication used primarily in the Ophthalmology office environment.
I'm turning it extends up for the treatment of post-surgical inflammation and pain on the sales side for your part of one point four million and extends a net product revenue for the second quarter after a near total Crackdown and cataract surgeries. And April extends the bounce back strongly and recorded a record month in June Bill little inserts do Ambulatory Surgery centers and hospitals are key metric of in a demand increased from only 64 inserts in April and cataract volumes were down 97% nationally to nearly 2300 inserts in June exceeding by 40% The previous previous monthly high and breaking the million dollar threshold in Market in a calendar month for the first time a threshold will be clear to get in July.
Despite the fact that many AFC shop. He's are still either not operating at capacity or operating in reduced capacity. The record month suggest extends that has earned it increased share of cataract surgery and the postcode environment.
We believe the market sees our hands free alternative to drop that's compelling and be expect to see this momentum carrying over into the third third quarter.
Adding to our confidence and extensive sales are two potential accelerators as we head into the second half of the Year. First. We initiated a new rebate program that is being well received especially by the large private equity-backed ASC can talk consolidators that now dominate the Cataract space. Secondly, we recently announced that to Medicare administrative contractors or Max no week off First Coast have established physician fee schedules for reimbursement of procedure code 0 362 CPT CPT code for the placement of a drug-eluting intracanalicular in service. I can make sense.
This means that the Physicians inserting extensive can expect a professional fee payments up between $95 and $115 for each insertion, which is separate from the reimburse yourself First Coast and novitas cover nearly 30% of all Medicare beneficiaries, in addition four of the remaining five Max have retired their non-coverage policies 803 5:16, and we eagerly await the publication of these schedules from them. Overall. We think these both represent significant catalysts that along with return to normal mode volumes for further help us build on the momentum. We are seeing what the extent of
Summary talk to the therapeutic to making important strides and development of its portfolio, but it's also being held by changes in the competitive market and the overall environment as we look at those prospects even notice prior to see a different Outlet today across the spectrum of way MD glaucoma dry eye disease or allergic conjunctivitis and the prevention of post-surgical pain and inflammation. Our products have progressed substantially without on. I'll turn the call over to my host name.
Thanks Anthony. Let me begin with an update on our back of the I program no txt. Ki is a virus or Ebola hydrogel implant containing access to them which has anti-tumor properties and it's delivered by intravitreal injection and designed to extend the durability of treatment for wet. AMD is being developed to treat patients with wet age-related macular degeneration and other wage diseases such a diabetic macular edema and retinal vein occlusion. We continue to their subjects in a multicenter open-label dose-escalation phase 1 clinical trial in Australia wage that is designed to assess the safety and tolerability of txt Ki as well as to assess preliminary biological activity by measuring anatomical and functional changes.
First two cohorts are not fully enrolled in a third cohort is currently enrolling the data demonstrates txt Ki in both cohorts is generally well-tolerated with a federal safety profile with no soul. Doctor Adverse Events reported to date while still early initial interim data suggests that there is a dose-response as evidenced by a greater clinical response in the second higher dose cohort compared first or S car and hired escort txt. Ki several treated subjects to a decrease in retro fluid is measured by decreases and interactional and or suburbs with the longest streets subject with wet age-related macular degeneration now out to 7 and 1/2 months without needing anti-vegf three months additionally Sub sub some patience and Kolb on the require frequent anti-vegf testing prior to enrollment in this study which showed to potentially not need rescue therapy for as long as ten months after being treated with o t x t t i
On the driver credit profile is still emerging. We are pleased with the interim data that shows interpret fuel injection of a t k i can potentially reduce interational and or subretinal fluid in terms of upcoming milestones for a txt Ki we're rolling a third cohort of patience for half. The patients will be ghosts at six hundred micrograms and half the patients will receive a 400 micrograms does and Thursday induction injection. We plan to give an update on this study at a medical conference in the fall. We are also on track to submit an exploratory IMD to the FDA by the end of the year and start dosing of the United States or web and the DME and retinal vein occlusion.
Moving to Oregon, program o t x t I see is a viral reservable travel cross containing hydrogen.
Delivered be an intracameral injection designed to deliver extended duration of IOP reduction. We continue to enroll subjects with primary open-angle glaucoma or ocular hypertension and a faith perspective multicenter open labeled this escalation clinical trial in the United States to evaluate the safety biological activity durability and tolerability low txt. I see you December 1st to fully enrolled call guard showed decreased IOP and patients receiving txt. I see that was comparable to current standard-of-care topical travel across place and then on study I bought it shows at the IOP remain consistently decreased for an extended duration of six to nine months in many subjects with a single implant and one subject that i o p control for over twenty one months with a single implant internet access to complete enrollment and cohort three same doses for one but using a more rapidly degrading Hydro implant and are currently enrolling cohort or to the smaller implant the lower-wage.
retargeting initiate Phase 2 clinical trial for a t s p i t and first half of 2021
Next we have some exciting programs to discuss in the area of ocular surface diseases mean which includes the large potential markets of dry eye and allergic bronchitis for dry. I be of Tupac TX CSI is addressing dry patients with chronic disease and we recently announced that we have a new program o t x d f d e d targeting patients with episodic or dry player. We've also completed phase three trials evaluating fixed ends up for the treatment of patients with follicular conjunctivitis.
Oh, she XTS is an intracanalicular cancer which combines two modalities commonly used to treat triac patients moti. XCS is designed to release cyclosporine for approximately three months to the ocular surface wage provide conclusion over that time period by releasing Lodi cyclosporine over an extended duration of time OT XCS. I has a potential to minimize what we believe is one of the biggest patience. Topical cycle score Stadium burning by combining drug release with some confusion OT XTS is potential to provide more rapid onset of symptomatic relief for patience and faith alone Roti XCS. I we've recently completed enrollment of the phase 1 clinical trial patients have been treated with no TX CSI for a number of weeks of Safety Committee has ma'am. I was supportive of moving to a phase 2 clinical trials. We remain on track if the data from the phase one comes to trial is payroll to begin enrolling The randomized placebo-controlled Phase 2 clinical trial.
You're we're very excited about the potential for this hands-free option in helping Drive patients receive the benefits of cyclosporine with a with a potentially greater tolerability and more rapid wage benefit. Very good therapy is currently available on the market.
Our newest product candidate o x o t x d e d is a low-dose intracanalicular insert effects of ozone for the treatment of patients with episodic dry eye disease or the corporate office of dragons to extend that this is a new product candidate with a lower dose and smaller insert size many of these these dry patients experience episodic players of their signs and symptoms, which we believe may be related to inflammation currently available topical steroids are used off-label for dry eye patients and that preservatives which can result in ocular surface toxicity. This may also lead to Adverse Events such as elevated. They may also lead to Adverse Events such as elevated IOP or cataracts if used chronically no txt. DED actually offers these patients the opportunity to be true. Unusable is this administer preservative-free hands-free steroid therapy because OTS b e d has a lower concentration of dexamethasone compared with next time we are able to
Leverage to extend the safety package that are you today. We find the file that investigative new drug application with the US FDA evaluating o t x d e d and drive a disease caused by the end of 2020 with the plan.
I moved directly into phase two clinical trials and patience and drive disease.
Conjunctivitis. We remain on track to submitted snda by the end of 2020 overall. We believe the data pack is highlighted compelling product profile targeting may actually change the current of standard of care for the one-time long-acting hands-free therapy for treatment of ocular issues associated with lawyer Clerk and divide us this snda impact with represent our first in office indication last night before trying to call over to Donald I would like to add that there continues to be significant interest and excitement and evaluation in many areas of unmet need with over 70 investigator-initiated trials request submitted. We currently have 14 iits that are active in enrolling subjects including to that it completed enrollment.
I would now like to turn the call back over to Donald. Thanks, Mike Gross product Revenue net of discounts rebates and returns which company refers to his total net product. Revenue was one point six million for the 3 months ended June Thirty twenty-twenty that product revenue of the extended and restore sealant and second quarter were 1.4 million and 0.2 million respectively research and development expenses for the second quarter where eight hundred dollars versus nine point four million dollars for the comparable period in 2019 and primarily reflect a decrease in personnel and unallocated cost to change channel restructuring announced in November of 2019 selling and marketing expense for the second quarter was six point two million dollars is compared to seven point two million dollars for the same quarter in 2019. Stemming primarily from a decrease in travel Consulting marketing and Conference expenses as a result of the code related slow down in the commercialization of the extensive.
Finally General and administrative expenses were five point 1 million in the second quarter of both 2020 and 2019 with a modest increase in facilities expenses being not being offset by decreased professional cost you $220 with respect to financial results for the second quarter. We reported a net loss thirty six point six million dollars wage loss of $0.64 per share on a basic and diluted basis this compares to a net loss of twenty four point five million dollars or a loss of $0.57 per share on a basic and diluted basis for the same. In 2019. The net loss for the second quarter included two point five million dollars and non-cash charges for stock-based compensation and depreciation compared to two point three million dollars for the same quarter in 2019.
In addition the net loss for the quarter included non-cash charge of $17 related to the change in the fair value of the derivative liability associated with our convertible notes primarily as a result of the significant increase in our stock price as compared to the prior quarter.
As of August 1st 2020 the company had approximately 63 million shares outstanding as of June Thirty twenty-twenty the company had eighty four point three million dollars in cash and cash equivalents versus forty eight point two million dollars at the end of q1. Went the cash balance benefited during the second quarter from forty eight point three million dollars in net proceeds generate a public offering stock in May and also from net proceeds of one point seven million dollars from the sale of common stock under the company's 2019 sales agreement under which the company may offer and sell its, a stock having aggregate proceeds of up to fifty million dollars from time to time approximately 1.3 million dollars of common stock remains available to be sold under the 2019 sales agreement off.
based on current plans and
Including related estimates of in speed of cash flows from extends and restore sealant product sales in cash outflows from operating expenses, the company believes that existing cash and cash equivalents as of June 30th, 2020 will enable the company to fund plan operating expenses that service obligations and capital expenditure requirements for at least the next twelve months. It's cash guidance is subject to various assumptions, including those related to the severity and duration of the covid-19 pandemic and expect to continue to Rebound in cataract surgeries beginning in the third quarter and other assumptions related to revenue expenses associated with the commercialization of extends a variable expense reductions and the pace of research and clinical development programs as well. As other aspects of the company's business. This concludes my comments on the second quarter Financial results, and I would like to turn the call back to Anthony for some summary thoughts.
Thanks, So before opening the call up to questions. Let me do a quick summary and wet AMD the performance of txt Ki in the clinic continues to support a product profile that could potentially set a new standard of care for durability. We look forward to providing further clinical updates later this fall and glaucoma. Oh txt. I see continues to support a cross profile that could potentially set the standard of care for patient compliance. We plan to advance that program into a phase 2 clinical trials in the first half of 2021.
And like other services fees for otx CSI for treatment of chronic dry eye disease. We have completed enrollment in Phase One and get successful plant enter phase two before year-end m e d r newly-announced treatment for acute dry. I we plan to file a phase to enabling IND before year-end and is accepted interface to you shortly thereafter.
Beyond I have these we remain on track to submit our snda Ford extended and allergic conjunctivitis by the end of the year
For it extends it in post-operative inflammation and pain we have seen accelerated momentum in sales update in June and now in July as well and are optimistic such momentum will continue in the in the quarter of the added benefits of a new rebate program and Medicare reimbursement of a procedure associated with extensive. We look forward to an even greater growth in the future.
So in summary has been a very productive quarter and we look forward to continued productivity in a second half of the year with a number of key catalysts within our Pipeline and continued momentum with extensive without our turn the call over for clubs.
Ladies and gentlemen. If you have a question, or a comment at this time, please press star then the one key on your touch-tone telephone if your question has been answered you wish to remove yourself from the queue, please press the pound key.
Our first question comes from Joe cats are with black forest Adler. Hey guys. Thanks so much for taking my questions here and congrats on the progress. Especially given the backdrop maybe first just a couple on Ki the the data update that we expect to see later this year. Should we expect just an update for the first twelve patients and the first two cohorts or is there potential just the initial data from the patients treated in the third cohort? And then maybe as a follow-up to that what are the plans once the exploratory? I'd be in the u.s. Is cleared are are the next steps. They're dependent on what you've seen in cohort three. Maybe you could just walk us through housing development program involves once you can dose in the u.s. Banks.
Thanks Joe. This is Mike speaking. So in terms of your first question, we we plan to give an update on T Ki in the fall. There are several meetings. We have targeted as you know, we will give an update on where we are with the first twelve patient cohort one color to we're currently actively in rolling over three and you know how enrollment goes and if we have something meaningful to say we may be able to give an update on cohort three. We're not committing to that at the moment as far as the exploratory i n d Club, you know what the plan is to file an exploratory in the US by the end of the year that exploratory MD would allow us a potentially to to treat patients with AMD off as well as diabetic macular edema and retinal vein occlusion can commonly we're working on some changes to the formulation in terms of coming for the higher dose implant birth.
And working on the tox studies which will will be going on in parallel and we would then do the do the updates to the formulation do the necessary talks work and then off to file put to start a phase 2 trial.
Okay. Got it. That's helpful. Maybe just to follow up in one on here. Do you guys have visibility into the extent of position utilization of o365? So what have you seen since the update of those two Maxi schedules and is 03562 something you guys can specifically promote to?
That's still a little early to say about the physician utilization. There was some resistance to code for 360 before it had consistent reimbursement simply because of the way the way the accounting worked in in some of the afc's they didn't like to have non-payments even though there's there was no cash outlay. Um, but what we getting now is it's really accumulating evidence of reimbursement across the board and we're seeing certainly reimbursement within First Coast and and novitas. We're also seeing some reimbursements in the other aspects during the other Mac have yet to issue a fee schedule. We are, you know collecting as much data as we can, you know clearly and we we are not going to Market this to directly to Physicians. This is something that that they all should be aware of through their their uh, their maximum through their their Administration. Um, and it is a it's a standard part of what we recommend when when using extended that they should code for Thursday.
Unknown Executive: BF-WATCH TV 2021
560 as well. We're not going to coach them on on how to get reimbursement.
Okay. Got it. Thanks so much for taking my questions again. Congrats on the progress here.
Unknown Executive: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix second quarter 2020 earnings conference call. At this time, all participants are in the listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, si
Next question comes from each and the HC Wainwright.
Thank you for taking my questions. My first question is could you give us some additional color? The timeline of development for wage is too dry candidates and which product could potentially reach the market first?
Donald Notman: Thank you, Kevin. Good morning, everyone, and thank you for joining us on our second quarter 2020 financial results and business update conference call. This morning before the open, we issued a press release providing an update on the company's product development programs and details of the company's financial results for the quarter ending June 30, 2020. The press release can be accessed on the investors portion of our website at investors.ocutx.com. Leading the call today will be Antony Mattessich, our President and Chief Executive Officer, who will provide a summary of our corporate developments and an update on the Dextensa commercial launch. Also speaking on the call today will be Dr. Michael Goldstein, our Chief Medical Officer, who will give an update on our clinical developments and pipeline.
Donald Notman: Following Michael's remarks, I will provide an overview of the financial highlights for the second quarter before turning the call back over to Antony for a summary and questions. As a reminder, on today's call, certain statements we will be making may be considered forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. In particular, any statements regarding our regulatory and product development plans, as well as our research activities, are forward-looking statements. These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted, including those risks described in our most recent Form 10-Q on file with the SEC. I will now turn the call over to Antony.
Yeah, I'll start off and then hand it off to Mike for maybe more specific discussion about how to bring these forward DED the project with dexamethasone. That is at the moment going to enter phase two probably slightly behind CSI. I'm given the nature of the trials and the shorter duration of treatment is probably likely to overtake seen a sign in its development. So even though it's it's yet to file the society in the states. It is probably going to be the one that reaches the market first that being said, there's a uh, a number of different opportunities. We can follow in terms of how we bring these to the market particular because we have active comparator imagine we would have access comparators in both of these indications.
I'll hand over to Mike to talk specifically about how we would conduct those trials going forward. Yeah, thanks. So you mentioned so cyclists for the CSI program is dead currently actively completed enrollment for the phase one program and we're on track to start the phase to program by the end of the year. That's a product that will release the cycle score and over approximately 83 months and it's really targeted more typical dry which is the chronic disease States and so we would need to do long-term safety and and and and all those sorts of things off. The TV program is using a lower concentration of the dexamethasone steroid, and it's really targeting these sort of a cute wage instead of dry or try I flares the plan there is to file the IND with the FDA by the end of the year and then move rapidly into clinical trials and we believed
Antony Mattessich: Thank you, Donald, and welcome everyone to Ocular Therapeutix's second quarter earnings report. I'm pleased to report that, despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular as we have positioned the business well for the second half of the year. As I've said in past calls, one of the great benefits of Ocular Therapeutix is that, despite being a small company, our technology platform allows us to advance many programs across several of the most valuable segments in ophthalmology, which is Retinal Diseases or RET-AMD. Glaucoma, Ocular Surface Disease, including Dry Eye Disease and Allergic Conjunctivitis, and Post-Surgical Inflammation and Pain.
You know based on what we already know about this product based on what we've learned from the extends that we can move right into to face to program in in Drive patience with these flyers off the target. There would be to have a product that lasts less than a month and it would not be chronic dosing. So anti mentioned, although the d d program will be on a second in terms of of work when when we start the trials. It should rapidly take a get the kind of head of CSI. Um and there we don't need to do long-term dosing, you know beating dosing for over a year or so. The ability to get to Market is going to be much quicker with the D D program.
Antony Mattessich: Beginning with the largest of these value drivers, wet AMD, the global market for retinal diseases was approximately $13 billion in 2019, and it's estimated to grow at 11% over the next five years. A key driver in the treatment selection for wet AMD is durability. The longer a treatment works to keep a patient without fluid on a single injection, the greater attractiveness of the treatment in general. Current standard of care typically has patients needing re-injection every four to eight weeks.
Got it. Thank you and just to follow up for Didi. Do you need to meet both sign and symptom in point in points in a pivotal trial and for CSI? Do you only need to be the surest test and point in a pivotal trial?
Antony Mattessich: In the space of the last few quarters, OTX-TKI, our wholly owned intravitreal tyrosine kinase inhibitor eluting implant designed to deliver up to six months of therapy with a single injection, has shown a favorable signal in the clinic and we believe it has the potential to set the standard of care for durability of treatment for wet AMD. We look forward to providing further clinical updates on this key program in the fall. In addition to OGX-TKI, Ocular is working on a second product for wet AMD with our partner Regeneron to develop an extended delivery, super-choroidal injection formulation of the FDA-approved VEGF trap in liver cells. As many of you know, this has been a longstanding collaboration. But what many may not know is that, in May, we successfully amended the collaboration whereby Regeneron will compensate Ocular Therapeutix on a cost-plus basis for all work performed under the preclinical portion of the collaboration. There is no change to the back-end economics of the original agreement to provide for potential option exercise fees and milestone payments of $305 million and tiered escalating royalties from the high single digits into the low to mid teens.
All right, great question. So in general for both indications for dry we are we are targeting a sign and symptom endpoint into adequate and well-controlled off. There are there are some exceptions one of which is is as you point out is is around sure where but but that would not be the target the target would actually be too long to to to get signs and symptoms into adequate and well-controlled trials.
Thank you.
Again, ladies and gentlemen. If you have a question or a comment at this time, please press the star. Then the one key on your touch-tone telephone. Our next question comes from De Leon with Raymond J.
Hi, thanks for taking a question and grabs on the progress to see sidd. Actually. Just wanted to ask you may be slightly different question. Um how what what's actually the comparative bar for these studies? Um, you know, what what you would need to show versus obviously dead, you know widely available drops and how you think about that and what's been the feedback from, you know, your discussions with clinicians of what they would want to seem to think about, you know, either in the chronic or or the acute setting to use uh an answer.
Antony Mattessich: We are thrilled to continue our work with Eugeneron, and we are more excited than ever about the potential value this collaboration could bring to OCU. Moving to Glaucoma, a market worth nearly $5 billion in global annual sales, where possibly the greatest unmet need is for a product that ensures better patient compliance. As we mentioned on the call last quarter, we have confidence in the regulatory path for OTX-TIC, our trial approach to eluting inter-chameral implants, and we believe our hydrogel platform can potentially offer additional safety and durability benefits. With a magnitude of IOP lowering at least as good as prostaglandin drops given in a clinical trial setting and a potential durability of 6 plus months from a single insert, we believe OTX-TIC has the potential to become standard of care for treatment of elevated IOP in glaucoma.
Thanks Dan. So it's a great question. So from a regulatory perspective, there are two potential Pathways for comparators. So the typical Pathways and to show statistical significance superiority, um compared to a vehicle comparator, um the other and and that's been sort of a traditional way that drugs in the drive space have gotten approved now that we have approval in the United States for Two drugs at least in The Chronic space cyclosporine. And and last name is there is the opportunity to go head-to-head with it with an active comparator and shown on. RT. So that would apply to o t x c s i m terms of OGX DET. There are no drugs currently approved in that acute. Um or uh, dry Eiffel airspace now there there may be a drug that gets approved.
Antony Mattessich: For the treatment of ocular surface diseases, such as dry eyes and allergic conjunctivitis, we have seen positive developments this quarter. In the treatment of dry eye disease, by far the largest segment of oculosurface. We now have two products. OCX-CSI is our cyclosporine intercanellicular insert for the treatment of chronic dry eye, and we have added OTX-DED, a product candidate designed to treat episodic dry eyes. With the addition of OTX-DED along with OTX-CSI, we now have two potentially transformative products.
Antony Mattessich: One to treat chronic forms of the disease and the other to treat acute, thereby effectively covering the broad spectrum of the approximate $5 billion dry eye disease market. For allergic conjunctivitis, we remain on track to file an SNDA application by the end of the year. Notably, allergic conjunctivitis could represent extensus' first ocular surface disease indication and be the first indication used primarily in the ophthalmology office environment. I'm turning to Dextenza for the treatment of post-surgical inflammation and pain. On the sales side, we reported $1.4 million in net product revenue for the second quarter.
Cuz here I think that's likely and if so, then that actually serve as an actor in an active comparator type trial.
Just calling up and saying what what positions are looking for. I mean clearly on the these these cycles for inside looking for something that has less burning and stinging and it has a more immediate onset of action. And and we feel that that the C S. I would be able to to answer both of those issues. And on the the the DED side they being able to treat a flare with a with a stage they would be looking for a product that that would be not abusable and in in our case where a physician administered and and is it a not abusable formulation of a steroid also something that would have a preservative which would also be the case for for CSI.
Antony Mattessich: After a near-total shutdown in cataract surgeries in April, Extensa bounced back strongly and recorded a record month in June. Billable inserts to ambulatory surgery centers and hospitals, our key metric of in-market demand, increased from only 64 inserts in April, when cataract volumes were down 97% nationally, to nearly 2,300 inserts in June, exceeding by 40% the previous pre-COVID monthly high and breaking the million dollar threshold in the US market in a calendar month for the first time. The threshold will be cleared again in July. In spite of the fact that many AFCs and HOPGs are still either not operating at capacity or operating at reduced capacity, the record month suggests that Extensa has earned an increased share of cataract volume in the post-COVID environment.
I think additionally one of these things that both of these products would offer that is unique in the environment currently is that currently there is no opportunity for Revenue generation for Physicians just Physicians offices, um in drug treatment of dry or dry eyes flare with CSI, and and DED both of them obviously would suck when used 364 for being deployed. So there's an opportunity to to to code for an additional procedure and they would be buying build products that would be purchased by a Traditions office which would create uh, opportunities from a rebate standpoint and also potentially from a marketing standpoint. So we think that this would we did not only a uh, a hole in the market in terms of the the South Africa see that's needed compared to two products that are on the market or will shortly be on the market but also in that creates a whole new opportunity for a a revenue generation from 4 position dead.
Antony Mattessich: We believe the market sees our hands-free alternative to drops as compelling, and we expect to see this momentum carrying over into the third quarter. Adding to our confidence in the expense of sales are two potential accelerators as we head into the second half of the year. First, we initiated a new rebate program that is being well-received, especially by the large, typically private equity-backed, ASC consolidators that now dominate the cataract space. Secondly, we recently announced that two Medicare Administrative Contractors, or MACs, Novitas and First Coast, will be eligible for Medicaid, and have established physician fee schedules for reimbursement of procedure code 0356. CPT code for the placement of a drug-eluting inter-cantilecular insert, including Nexensis. What this means is that physicians inserting Dextenza can expect a professional fee payment of between $95 and $115 for each insertion.
great, and if I can just
Ask one follow-up on that since you brought it up. How do you from your market research? How do you think you know, the the actual consumer would feel about an insert? How long do you are there certain features of either compliant or utilization that that's been experience but the drops that you know, I mean there's a convenient angle or or just actually uh treatment effect angle that's apparent in in kind of understood by the clinical Community or you know with that require more uh education on your part.
It's pretty Universal. But any time you do research on drug therapies that people don't like drops. That's that's a fairly easy thing to demonstrate. The second thing is dead is certainly that that relates to cyclosporine the burning and stinging of the drops if it's associated with having to pulse dose, so that that is it's pretty clear that if you can you can you can get rid of those two issues that you you have a a win with with with patients. But also the immediate onset of action is you look at the if we're stasis in particular and off the big grass. If you look at the Persistence of therapy patients drop off very very rapidly and the number of scripts that that people are still taking after six months or after a year is it is exceedingly low mostly because of the the slow onset and because it's singing burning so in all of those situations, I think we would do very very well with patients even if there was a selfie environment birth
Antony Mattessich: First Coast and Novitas cover nearly 30% of all Medicare benefits. In addition, 4 of the remaining 5 MACs have retired their non-coverage policies for 0356T, and we eagerly await the publication of fee schedules from them.
Antony Mattessich: Overall, we think these both represent significant catalysts that, along with a return to more normal cataract volumes, will further help us build on the momentum we are seeing with Xtend. In summary, Ocular Therapeutix is making important strides in the development of its portfolio, but it is also being helped by changes in the competitive market and the overall environment. As we look at Ocular's prospects even a few quarters ago, we see a different outlook today. Across the spectrum of wet AMD, glaucoma, dry eye disease, or allergic ductivitis, and the prevention of post-surgical pain and inflammation, our products have progressed substantially. The panel will now turn the call over to Mike Goldstein.
Like if you want to yeah, it's just to add to that. I mean you bring up a great point. And so one of the key ways that we treat dry eye currently is the pump flow collusion with with dead. So so putting placing something into the catalytic keyless is is really standard of care for for dry patients. So so in terms of that, it doesn't really sucks. I'm with which change is that not only do you get the pump inclusion, but you're actually getting an active drug released over a period of time.
Michael Goldstein: Thank you. Let me begin with an update on our Back of the Eye program. OTX-TKI is a bioresorbable hydrogel implant containing axitinib, which has anti-angiogenic properties and is delivered by intravitreal injection and designed to extend the durability of treatment for wet AMT, is being developed to treat patients with wet, age-related macular degeneration and other retinal diseases such as diabetic macular edema and retinal vein inflation. We continue to recruit subjects in The first two cohorts are now fully enrolled, and a third cohort is currently enrolling. The data demonstrate that OTX-TKI in both cohorts is generally well-tolerated with a favorable safety profile, with no serious ocular adverse events reported to date.
Michael Goldstein: While still early, initial interim data suggests that there is a dose response, as evidenced by a greater clinical response in the second, higher dose cohort compared to the first, lower dose cohort. In a higher dose cohort, OTX-PKI, several treated subjects showed a decrease in retinal fluid as measured by decreases in inter-retinal and or sub-retinal fluid, with the longest treated subject with wet age-related macular degeneration now out to seven and a half months without needing anti-VEGF treatment. Additionally, some patients in Cohort 1 who have required frequent anti-VEGF dosing prior to enrollment in this study were shown to potentially not need rescue therapy for as long as 10 months after being treated with OTX-TKI.
That's great. Very good answers. Thank you very much.
Our next question comes from Jonathan Walden with JMP Securities. Hi, good morning. And thanks for taking the questions. A lot of might have been answered. But just a couple first on Thursday. We're getting further along the launch and we've gotten past covid-19 have some of these medical administrative contractors coming on board. Have you thought about providing guidance either later this year or next to give us a better feel for long-term demand?
Yeah, we we will be issuing guidance at some point in the future. But we have three very large confounding factors that we're really going to be able to to send what what it's going to do with extends the same over the next quarter the 1st, which is by far the largest in and most uncertain to be able to to judge is is what the impact of code is going to have on elective surgeries. We we have no hard data, but but from anecdotal data, we get back from our fields. We we feel that it's probably about fifty percent of normal at the moment and appears to be holding steady despite the fact that some areas are starting to to get more intent. Um, the second is the rebate program, which is really brand new. Um, we probably going to to see the the maximum effects in the third quarter rather than the third quarter, but we will see in effect in the third quarter. And then finally it's the reimbursement of 360 because of those three factors the the uncertainty of birth
Michael Goldstein: While the drug product profile is still emerging, we are pleased with the interim data that show intravitreal injection of a TKI can potentially reduce intraretinal and or subretinal fluid. In terms of upcoming milestones for OTX-TKI, we're enrolling a third cohort of patients where half the patients will be dosed with 600 micrograms, and half the patients will receive a 400 microgram dose of an anti-VEG
in the future after where we don't feel the providing forward guidance at the moment is going to be terribly useful, but I believe it by the end of the third quarter we should
Michael Goldstein: We plan to give an update on this study at a medical conference in the fall. We are also on track to submit an exploratory IMD to the FDA by the end of the year and start marketing in the United States for WET-AMD, DME, and retinal vein occlusion. Moving to our glaucoma program, OTX-TIC is a bioresorbable, trabel-cross-containing hydrogel implant delivered via an inter-chameral injection designed to deliver extended duration of IOP reduction. We continue to enroll subjects with primary open-angle glaucoma or ocular hypertension in a Phase I prospective multi-center open-label dis-escalation clinical trial in the United States to evaluate the Data from the first two fully enrolled cohorts showed decreased IOP in patients receiving OTX-TISP that was comparable to current standard of care topical travel across the place in the non-study eye. The data showed that the IOP remained consistently decreased for an extended duration of 6-9 months in many subjects with a single implant, and one subject had IOP control for over 21 months with a single implant.
Have a bit of a read on what those what those three major factors are going to have they're going to impact us going forward. And as soon as we feel confident in a in in a um in in a go-forward scenario event, then we'll we'll definitely start guiding the market appropriately great. And then just one look at across the landscape brochure recent data and wet AMD for delivery system. I was wondering just your thoughts on that approach and anything any comments on their data banks. Yeah. I I think it's it's obviously a very large market and what people are seeking is a longer dirt or more durable therapy. Um, so I think the Roche toes is super interesting facts. Um, it is a a surgical procedure um, and you know, there's there's certain technical issues that in terms of of of of delivery through that system, but I think that that looks like a pig
Anything in the attractive option what we offer is, you know, probably employ wave of delivering the medication and really the way it works is the impact is inserted using basically the same techniques that people use for current anti-vegf therapy. So it wouldn't require any change of skill set. It would be able to be placed off by reading a specialist usually most of those as well as non Retina Specialists who are are making up a larger and larger percentage of those people doing anti-vegf injections. So, you know in many ways, I think they should be should be complementary to each other.
Michael Goldstein: In terms of next steps, we have completed enrollment in Cohort 3, the same dose as Cohort 1, but using a more rapidly degrading hydrogel implant, and are currently enrolling Cohort 4, which has a smaller implant but a lower dose. We are targeting and initiating a Phase II clinical trial for OTX-PIC in the first half of 2021. Next, we have some exciting programs to discuss in the area of ocular surface diseases, which include the large potential markets of dry eye and allergic connectivitis. For dry eye, we have two programs.
Michael Goldstein: OTX-CSI is addressing dry eye patients with chronic disease, and we recently announced that we have a new program, OTX-DED, targeting patients with episodic or dry eye flare. We've also completed phase three trials evaluating Vexenza for the treatment of patients with allergic connectivitis. OCX-CSI is an intracanellicular insert that combines two modalities commonly used to treat dry eye patients. OCX-CSI is designed to release cyclosporine for approximately three months onto the ocular surface and to provide punctal occlusion over that time period. By releasing a low dose of cyclosporine over an extended duration of time, OTX-CSI has the potential to minimize what we believe is one of the biggest patient complaints about topical cyclosporine, stinging and burning. Furthermore, by combining drug release with punctal occlusion, OTX-CSI has the potential to provide more rapid onset of symptomatic relief for patients than cyclosporine alone.
Great. Thanks, Michael and congrats and all the progress.
And since there are no further questions at this time. This does conclude the ocular therapeutix conference call. You may all disconnect and have a wonderful day.
Thursday Thursday
Michael Goldstein: For OTX-CSI, we have recently completed enrollment in the Phase I clinical trial, and patients have been treated with OTX-CSI for a number of weeks. The Safety Committee has met and is supportive of moving to Phase 2. We remain on track, if the data from the Phase 1 clinical trial is favorable, to begin enrolling the randomized, double-mask, placebo-controlled Phase 2 clinical trial by the end of the year.
Michael Goldstein: We are very excited about the potential for this hands-free option in helping dry eye patients receive the benefits of glycosporin with potentially greater tolerability and more rapid clinical benefit compared to therapies currently available on the market. Our newest product candidate, OX-OTX-DED, is a low-dose, intercanalicular insert of betamethadone for the treatment of patients with episodic dry eye disease. While it incorporates the same active drug as Xpenza, this is a new product candidate with a lower dose and smaller insert size.
Michael Goldstein: Many of these dry eye patients experience empathetic flares of their signs and symptoms, which we believe are likely related to inflammation. Currently, available topical steroids are used off-label for dry eye patients and have preservatives that can result in ocular surface toxicity. This may also lead to adverse events such as elevated IOP or cataracts if used chronically. OTX-DED potentially offers these patients the opportunity to be treated with a non-abusable, physician-administered, preservative-free, and hands-free steroid therapy. Because OTX-DED has a lower concentration of dexamethasone compared with Dextenza, we are able to leverage the Dextenza safety package generated to date. We plan to file an investigative new drug application with the U.S. FDA evaluating OTX-DED for dry eye disease by the end of 2020, with a plan to move directly into Phase II clinical trials in patients with dry eye disease.
Michael Goldstein: In electroconjunctivitis, we remain on track to submit an SNDA by the end of 2020. Overall, we believe the data package highlights a compelling product profile targeting an unmet need that could potentially change the current standard of care with a one-time, long-acting, hands-free therapy for the treatment of ocular itching associated with electroconjunctivitis. This FNDA, if approved, would represent our first in-office indication. [inaudible] Before turning the call over to Donald, I would like to add that there continues to be significant interest and excitement in evaluating Dick's DENSA in many areas of unmet need, with over 70 investigator-initiated trial requests submitted. We currently have 14 IITs that are active and enrolling students, including two that have completed enrollment.
Michael Goldstein: I would now like to turn the call back over to Donald.
Donald Notman: Thanks, Mike. Gross product revenue net of discounts, rebates, and returns, which the company refers to as total net product revenue, was $1.6 million for the three months ended June 30, 2020. The Net Product Revenue of Dick Stenzel and Richard Seelant in the second quarter were $1.4 million and $0.2 million, respectively. Research and development expenses for the second quarter were $8 million versus $9.4 million for the comparable period in 2019, and primarily reflect a decrease in personnel and unallocated costs due to organizational restructuring announced in November of 2019. Selling and marketing expense for the second quarter was $6.2 million, as compared to $7.2 million for the same quarter in 2019, stemming primarily from a decrease in travel, consulting, marketing, and conference expenses as a result of the COVID-related slowdown in the commercialization of Extensa. Finally, general and administrative expenses were $5.1 million in the second quarter of both 2020 and 2019, with a modest increase in facilities expenses being offset by decreased professional costs in Q2 2020.
Donald Notman: With respect to financial results for the second quarter, we reported a net loss of $36.6 million, or a loss of 64 cents per share on a basic and diluted basis. This compares to a net loss of $24.5 million, or a loss of 57 cents per share on a basic and diluted basis for the same period in 2019. The net loss for the second quarter included $2.5 million in non-cash charges for stock-based compensation and depreciation compared to $2.3 million for the same quarter in 2019. In addition, the net loss for the quarter includes a non-cash charge of $17 million related to the change in the fair value of the derivative liability associated with our convertible notes, primarily as a result of the significant increase in our stock price as compared to the prior quarter.
Donald Notman: As of August 1, 2020, the company had approximately 63 million shares outstanding. Additionally, as of June 30, 2020, the company had $84.3 million in cash and cash equivalents versus $48.2 million at the end of Q1 2020. The cash balance benefited during the second quarter from $48.3 million in net proceeds generated from a public offering of stock in May and also from net proceeds of $1.7 million from the sale of common stock under the company's 2019 sales agreement, under which the company may offer and sell its common stock, having aggregate proceeds of up to $50 million from time to time. Approximately 1.3 million dollars of common stock remains available to be sold under the 2019 sales agreement. Based on current plans and including related estimates of anticipated cash flows from Dexenza and Reshure sealant product sales and cash outflows from operating expenses.
Donald Notman: The company believes that its existing cash and cash equivalents, as of June 30, 2020, will enable it to fund planned operating expenses, debt service obligations, and capital expenditure requirements for at least the next 12 months. This cash guidance is subject to various assumptions, including those related to the severity and duration of the COVID-19 pandemic and the expected continued rebound in cataract surgeries beginning in the third quarter, and other assumptions related to revenue and expenses associated with the commercialization of dextenza, variable expense reductions, and the pace of research and clinical development programs, as well as other aspects of the company's business. This concludes my comments on the second quarter's financial results, and I would like to turn the call back to Antony for some summary thoughts.
Antony Mattessich: Thank you. Before opening the call up for questions, let me give you a quick summary. In wet AMD, the performance of OTX TKI in the clinic continues to support a product profile that could potentially set a new standard of care for durability. We look forward to providing further clinical updates later this fall. In glaucoma, OTXTIC continues to support a product profile that could potentially set the standard of care for patient compliance.
Antony Mattessich: We plan to advance that program into a phase two clinical trial in the first half of 2021. For ocular surface disease, or OTX-CSI, for treatment of chronic dry eye disease, we have completed enrollment in Phase 1, and if successful, plan to enter Phase 2 before year end. For OTxDED, our newly announced treatment for acute dry eye, we plan to file a Phase 2 enabling IND before year-end, and if accepted, enter Phase 2 shortly thereafter. Additionally, beyond dry eye disease, we remain on track to submit our SNDA for Dixdenza and allergic ductivitis by the end of the year. For Dextenza and post-operative inflammation and pain, we have seen accelerated momentum in sales updates in June and now in July as well, and we are optimistic that such momentum will continue in the quarter.
Antony Mattessich: With the added benefits of a new rebate program and Medicare reimbursement of the procedure associated with Expensa, we look forward to even greater growth in the future. So, in summary, it has been a very productive quarter, and we look forward to continued productivity in the second half of the year with a number of key catalysts within our pipeline and continued momentum with Attenza. With that, I will turn the call over to you for questions.
Unknown Executive: Ladies and gentlemen, if you have a question or a comment at this time, please press the star and then the one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the found key.
Joseph Michael Catanzaro: Our first question comes from Joe Catanzaro with Piper Sound. Hey guys, thanks so much for taking my questions here and congratulations on the progress, especially given the backdrop. Maybe first, just a couple on TKI, the data update that we expect to see later this year. Should we expect just an update for the first 12 patients in the first two cohorts, or is there the potential to see initial data from the patients treated in the third cohort? And then maybe as a follow-up to that, what are the plans once the exploratory IND in the U.S. is cleared? Are the next steps there dependent on what you see in Cohort 3? Maybe you could just walk us through how the development program evolves once you can dose it in the U.S. Thanks.
Michael Goldstein: Thanks, Joe. This is Mike speaking.
Michael Goldstein: So, in terms of your first question, we plan to give an update on TKI in the fall. There are several meetings we have targeted. As you note, we will give an update on where we are with the first 12 patients in Cohort 1 and Cohort 2. We're currently actively enrolling Cohort 3, and depending on how enrollment goes, and if we have something meaningful to say, we may be able to give an update on Cohort 3. We're not committing to that at the moment.
Michael Goldstein: As far as the exploratory IND, as you know, the plan is to file an exploratory IND in the U.S. by the end of the year. That exploratory IND would allow us to potentially treat patients with AMD as well as diabetic macular edema and retinal vein occlusion. And commonly, we're working on some changes to the formulation in terms of coming up with a higher dose implant and working on the tox studies, which will be going on in parallel. And we would then do the updates to the formulation, do the necessary tox work, and then look to start a phase two trial.
Joseph Michael Catanzaro: Okay, got it. That's helpful. Maybe just a follow-up question and one on Dextensa here. Do you guys have visibility into the extent of physician utilization of O3-560? If so, what have you seen since the update of those two MACP schedules? And is O3-560 something you guys can specifically promote?
Antony Mattessich: It's still a little early to say about physician utilization. There was some resistance to code for 356T before it had consistent reimbursement, simply because of the way the accounting worked in some of the ASCs. They didn't like to have non-payments, even though there was no cash outlay.
Antony Mattessich: We are collecting as much data as we can. Clearly, we are not gonna market this directly to physicians. This is something that they should be aware of through their MACs and through their ASC administration. And it's a standard part of what we recommend when using Dextenza that they should code for 356C as well. But we're not gonna coach them on how to get reimbursed.
Joseph Michael Catanzaro: Okay, I got it. Well, thanks so much for taking my questions again. Congratulations on the progress here.
Yi Chen: Thanks, Joe.
Antony Mattessich: Our next question comes from Yi Chen with HC Wayne Radio. Thank you for taking my questions. The first question is, could you give us some additional color on the timeline of development for those two dry candidates and which product could potentially reach the market first?
Antony Mattessich: Um, yeah, I'll start off and then hand it off to Mike for maybe more specific. DDD is a product with dexamethasone that is, at the moment, going to enter Phase II, probably slightly behind CSI. However, given the nature of the trials and the shorter duration of treatment, it's probably likely to overtake CSI in its development. So even though it's yet to file its IND in the States, it is probably going to be the one that reaches the market first. That being said, there are a number of different opportunities we can follow in terms of how we bring these to the market, particularly because we have active comparators, or we imagine we would have active comparators in both of these indications. I'll hand it over to Mike to talk specifically about how we would conduct those trials going forward.
Michael Goldstein: Thanks, Yi. As Antony mentioned, the CSI program is currently active. We've completed enrollment in the Phase I program, and we're on track to start the Phase II program by the end of the year. That's a product that will be released to Cyclosporine over approximately three months. And it's really targeted the more typical dry eye, which is in the chronic disease phase. And so we would need to do long-term safety studies and all those sorts of things.
Michael Goldstein: The DED program is using a lower concentration of the dexamethasone steroid, and it's really targeting these sort of acute onset of dry eye or dry eye flares. The plan there is to file the IND with the FDA by the end of the year and then move rapidly into clinical trials. And we believe, you know, based on what we already know about this product, based on what we've learned from Dextenza, that we could move right into a Phase II program in dry eye patients with these acute flares. The target there would be to have a product that lasts less than a month, and it would not be chronic dosing. So, as Anthony mentioned, although the DED program will be second in terms of work when we start the trials, it should rapidly get ahead of CSI. And there we don't need to do long-term dosing, you know, meaning dosing for over a year. So the ability to get to market is going to be much quicker with the DED program.
Yi Chen: Got it. Thank you. And just to follow up, for DED, do you need to meet both the sign and the synctin endpoints in a pivotal trial? And for CSI, do you only need to meet the Schirmer's Test Endpoint in a Pivotal Trial?
Michael Goldstein: Yeah, great question. So, in general, for both indications for dry eye, we are targeting a sign and symptom endpoint in two adequate and well-controlled trials. There are some exceptions, one of which, as you point out, is around Shermer, but that would not be the target. The target would actually be to get signs and symptoms in two adequate and well-controlled trials.
Dane Vincent Leone: Thank you. Again, ladies and gentlemen, if you have a question or a comment at this time, please press the star then the 1 key on your touchtone telephone. Our next question comes from Dane Leone with Raymond J.
Dane Vincent Leone: Hi, thanks for taking the question and congrats on the progress with CSI and DED. I actually just wanted to ask a slightly different question. How what what's actually the comparative bar for these studies? you know, what you would need to show versus, obviously, widely available drops and how you think about that, and what's been the feedback from your discussions with clinicians about what they would want to see to think about, you know, either in the chronic or the acute setting to use an insert.
Michael Goldstein: Thanks, Dane. So, it's a great question. From a regulatory perspective, there are two potential pathways for comparators. The typical pathway has been to show statistical significance superiority compared to a vehicle comparator. The other, and that's been sort of the traditional way that drugs in the drive space have gotten approved. Now that we have approval in the United States for two drugs, at least in the chronic space, cyclosporine and lofitigrass, there is the opportunity to go head-to-head with an active comparator and show non-inferiority. So that would apply to OTX-CSI. In terms of OTX-DED, there are no drugs currently approved in that acute or dry eye flare space. Now there may be a drug that gets approved later this year, and we think that's likely, and if so, then that could potentially serve as an active comparator treatment.
Antony Mattessich: Just following up on saying what physicians are looking for. I mean, clearly...
Unknown Executive: The Bulletproof Executive, 2013
Antony Mattessich: And on the DED side, being able to treat a flare with a steroid, they would be looking for a product that would be non-abusable, and in our case, it's physician administered and is a non-abusable formulation of a steroid, also something that wouldn't have a preservative, which would also be the case for CSI. But I think additionally, one of the things that both of these products would offer that is unique in the environment currently is that currently, there is no opportunity for revenue generation for physicians and physicians' offices. That would be purchased by the physician's office, which would create opportunities from a rebate standpoint and also potentially from a profit margin. So, we think that this would...
Dane Vincent Leone: Great. And if I could just ask one follow-up question on that, since you brought it up. How do you, from your market research, how do you think, you know, the actual consumer would feel about an insert? Do you, are there certain features of either compliance or utilization that's been experienced with the drops that, you know, either there's a convenience angle or just actually a treatment effect angle that's apparent and kind of understood by the clinical community? Or, you know, would that require more education on your part?
Antony Mattessich: Well, it's pretty universal that anytime you do research on drop therapies, people don't like drops. That's a fairly easy thing to demonstrate.
Antony Mattessich: The second thing is, certainly as it relates to cyclosporine, the burning and stinging of the drops that's associated with having to pulse dose. So it's pretty clear that if you can get rid of those two issues, you have a win with patients. [inaudible] Situations I think I think we would do very, very well with patients even if there was a self-paying environment, but Mike, maybe you want to
Michael Goldstein: Yeah, so just to add to that, and you bring up a great point, Dane, one of the key ways that we treat dry eye currently is with punctal occlusion with punctal plugs. So putting something into the canaliculus is really standard of care for dry eye patients. So in terms of that, this doesn't really change the paradigm, which changes that not only do you get punctal occlusion, but you're actually getting an active drug released over a period of time.
Dane Vincent Leone: That's great. Very good answers. Thank you very much.
Jonathan Patrick Wolleben: Our next question comes from Jonathan Wolleben with JMT Securities.
Jonathan Patrick Wolleben: Hi, good morning. Thanks for taking the questions. A lot of mine have been answered, but just a couple. First, on Dextenza. Now we're getting further along in the launch, and we've gone past COVID, and you have some of these medical administrative contractors coming on board. Have you thought about providing guidance, either later this year or next, to give us a better feel for long-term demand?
Antony Mattessich: Yeah, we will be issuing guidance at some point in the future, but we have three very large confounding factors that we're really going to be able to sense what they're going to do with extensive sales over the next quarter. The first, which is by far the largest and most uncertain to be able to judge, is what the impact of COVID is going to have on elective surgery. We have no hard data, but from the anecdotal data we get back from our fields, we feel that it's probably about 50% of normal at the moment and appears to be holding steady despite the fact that some areas are starting to get more intense. The second is the rebate program, which is really brand new. We're probably going to see the maximal effects in the fourth quarter rather than the third quarter, but we will see an effect in the third quarter. And then, finally, there was the reimbursement of $3,516.
Antony Mattessich: Because of those three factors, the uncertainty extends into the future enough to where we don't feel that providing forward guidance at the moment is going to be terribly useful. But I believe that by the end of the third quarter, we should have a bit of a read on what those three major factors are going to be, and how they're going to impact us going forward. And as soon as we feel confident in a go-forward scenario, we'll definitely start guiding the market appropriately.
Jonathan Patrick Wolleben: Great, and then just one looking across the landscape, Roche recently presented some phase 3 data in wet AMD for a port delivery system. I was wondering just your thoughts on that approach and any comments on their data. Thanks.
Michael Goldstein: Yeah, I mean, I think it's obviously a very large market, and what people are seeking is a longer, more durable therapy. So I think the Roche data is super interesting.
Michael Goldstein: It is a surgical procedure, and, you know, there are certain technical issues in terms of delivery through that system. But I think that that looks like a really interesting and attractive option. What we offer is, you know, probably a simpler way of delivering the medication. The way the TTI works is the implant is inserted using basically the same techniques that people use for current anti-VEGF therapy. So it wouldn't require any change in skill set. It would be able to be placed by retina specialists who are doing most of those injections, as well as non-retina specialists who are making up a larger and larger percentage of those people doing anti-VEGF injections.
Michael Goldstein: Great. Thanks, Michael, and congrats on all the progress. Thanks, Dalton. Thanks, Tom.
Unknown Executive: Since there are no further questions at this time, this does conclude the Ocular Therapeutix conference call. You may all disconnect at this time.
Unknown Executive: Since there are no further questions at this time, this does conclude the Ocular Therapeutix conference call. You may all disconnect and have a wonderful day.
Unknown Executive: transcript Emily Beynon